VP Head Clinical Development (non-oncology) at Hengrui Europe Therapeutics AG

Job content

Hengrui is the biggest Chinese pharma company with 25’000 employees, headquartered in Shanghai. With strong research focus in oncology, diabetes and metabolic diseases, autoimmune diseases, HIV, we have just started transforming into a global player. In 2020, we started establishing our entities in Europe and USA. We are building a new clinical R&D unit headquartered in Basel, Switzerland. We are also building three pre-clinical labs in Switzerland and England with focus on antibody engineering, mRNA therapeutics and target discovery. We are bringing top European pharma talent to help us build a new exciting international team in the heart of Europe.

Job Summary:

Responsible for driving the Europe or global clinical development strategies and execution for investigational and/or marketed products in Therapeutic Areas (TA) outside of Oncology. That means especially Diabetes and Cardiometabolic diseases, Auto-immune diseases, Cancer-induced Pain, Infectious diseases, and further areas.

The incumbent will be responsible for providing critical input into the strategy, development, management and implementation of Phase 1-4 clinical studies by closely working with the Clin Ops colleagues; providing Europe medical input to HQ Development teams on clinical development plan and LCM; leading multi-disciplinary teams charged with guiding clinical development and subsequent regulatory submissions and will directly manage Medical Directors and Clinical Scientists responsible for the design and execution of first in human through registration-enabling studies. This role will serve as the primary representative for the TAs to both the internal and external stakeholders, including executive leadership, development partners, and Europe and global regulatory agencies.

Tasks

• Represent Europe clinical science line function on global program team(s) and contribute to strategic planning and execution of clinical development plan in the aforementioned TAs with Europe inputs & deliverables
• Lead the development of clinical study protocols, protocol amendments, study guides, protocol training materials, and other clinical study related documents
• Perform medical monitoring (safety data review and identify potential signals), responses to site inquiries, and work with CRO medical monitors when appropriate
• Take medical responsibility in data analysis and interpretation, reporting and communication - ensure consistency and relevance of medical content and scientific messages across Clinical Study Report, health authority briefing books, and NDA/BLA submission documents, etc.
• Contribute to the operational aspects of study conduct and patient enrollment efforts including participation in site training, initiation and activation and subsequent site engagement activities
• Maintain focus on robust study conduct and quality data generation
• Demonstrated ability to develop unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape.
• Prior experience interacting effectively and successfully with regulatory agencies is essential.
• Solid knowledge of compliance and global regulatory requirements (ICH) for development of pharmaceutical candidates / products is required.
• Proven ability to represent the Company’s interests effectively in interactions with partners and regulatory agencies.
• Proven ability to “build a case,” both with internal scientific management and the Company’s partners / collaborators.
• Ability to lead a dynamic group in a fast-paced and hands-on environment.
• Effective written and verbal communications and interpersonal skills with all levels.
• Must have strong consensus-building skills and the ability to lead multi-disciplinary teams towards sound decision-making.
• Excellent scientific standing among peers and the ability to address issues with scientific rigor and creative solutions.
• Ability to develop and implement strategic growth plans.
• May be required to assist in other departments
  

Requirements

Knowledge / Skills / Abilities:

• Europe board-certified or -eligible (or foreign-equivalent) MD with internal medicine and/or subspecialty training and a good track record as industrial physician experience in Europe-based Pharma/Biotech/CRO) is required
• Phase 2/3 clinical development of products within the TA leading to successful regulatory submission is required (experience in solid tumor area is preferred)
• Recognized expertise in clinical trials: working understanding of statistical principles, medical monitoring; demonstrated ability to perform literature research, analyze and author clinical trial publications.
• Has working knowledge of GCP, ICH, Europe FDA and EMEA regulations
• Excellent communication and collaboration skills and experience working in cross-functional groups
• Experience communicating and interacting with investigators, KOLs, and advisors
• Experience working with the principles and techniques of data analysis, interpretation and clinical relevance
• Ability to work collaboratively with cross-functional team to support management of large volumes of data
• Ability to operate and thrive in a fast-paced environment; demonstrated flexibility
• Demonstrated success of taking initiative in a team setting
• Comfortable with ambiguity, yet be self-motivated and timeline driven
• Prior leadership experience is required
• Ability to travel up to 20% as needed
  

I look forward to receiving your application.